SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System
FDA 510(k) K180194 · Paragonix Technologies, Inc.
510(k) numberK180194
Submission
- Device name
- SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System
- Applicant
- Paragonix Technologies, Inc.
Braintree, MA, US - Received
- January 24, 2018
- Decision date
- March 30, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSB – System And Accessories, Isolated Heart, Transport And Preservation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5880
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code MSB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222535 | OCS Lung Donor Flush SetMSB · Traditional | TransMedics, Inc. | 11/18/2022SE |
| K211314 | OCS Lung SolutionMSB · Traditional | TransMedics, Inc. | 07/29/2021SE |
| K190063 | Servator C SALF SolutionMSB · Traditional | S.A.L.F. Spa | 08/14/2019SE |
| K182735 | Paragonix SherpaPak Cardiac Transport SystemMSB · Special | Paragonix Technologies | 10/19/2018SE |
| K143074 | Sherpa Pak Cardiac Transport SystemMSB · Special | Paragonix Technologies, Inc. | 11/25/2014SESK |
| K133432 | Sherpa Pak Cardiac Transport SystemMSB · Traditional | Paragonix Technologies, Inc. | 02/21/2014SE |
| K123326 | Sherpa Pak Cardiac Transport SystemMSB · Traditional | Paragonix Technologies, Inc. | 02/06/2013SE |
| K081997 | Perfadex with ThamMSB · Special | Vitrolife Sweden AB | 10/09/2008SE |
| K032794 | CustodiolMSB · Traditional | Dr. Franz Kohler Chemie GmbH | 04/05/2004SE |
| K022730 | Perfadex Solution for Lung PreservationMSB · Traditional | Vitrolife AB | 10/27/2003SE |
More from Vitrolife AB
| 510(k) | Device | Decision |
|---|---|---|
| K254305 | BAROguard Donor Lung Preservation SystemKDN · Special | 01/30/2026SE |
| K234060 | KIDNEYvault Portable Renal Perfusion SystemKDN · Traditional | 10/23/2024SE |
| K223874 | BAROguardKDN · Traditional | 08/15/2023SE |
| K201048 | SherpaPak Pediatric Liver Transport SystemKDN · Traditional | 07/02/2020SE |
| K191440 | Paragonix SherpaPak Pancreas Transport SystemKDN · Traditional | 12/20/2019SE |
| K182735 | Paragonix SherpaPak Cardiac Transport SystemMSB · Special | 10/19/2018SE |
| K143074 | Sherpa Pak Cardiac Transport SystemMSB · Special | 11/25/2014SESK |
| K143054 | Sherpa Pak Kidney Transport SystemKDN · Special | 11/25/2014SESK |
| K133694 | Sherpa Pak TransporterKDN · Traditional | 05/23/2014SE |
| K133432 | Sherpa Pak Cardiac Transport SystemMSB · Traditional | 02/21/2014SE |
Questions and answers
When was SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System cleared by the FDA?
SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System (K180194) received a 510(k) decision of Substantially Equivalent on March 30, 2018, 65 days after the submission was received.
What is the product code of K180194?
The FDA product code is MSB – System And Accessories, Isolated Heart, Transport And Preservation, a Class II (moderate risk) device regulated under 21 CFR 876.5880.